N
Patient 1
DEVICE STILL IMPLANTED; NOT RETURNED.
MAUDE MDR 6237397
- MDR report key
- 6237397
- Report number
- 3005025697-2017-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-12
- Date received
- 2017-01-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. RANDY HOYT
- Address
- 2800 PATTON ROAD SAINT PAUL MN 55113 US
- Phone
- 651-651-6517
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAESTRO RECHARGEABLE SYSTEM | ANTERIOR LEAD | ENTEROMEDICS, INC. | PIM | 2200A-47E | 2200A-47E | CR-01825 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
THIS SUBJECT IS A PARTICIPANT IN THE (B)(6) CLINICAL TRIAL. THIS SUBJECT WAS ORIGINALLY IN THE CONTROL ARM OF THE TRIAL AND UNDERWENT IMPLANTATION OF THE ACTIVE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2014. SUBJECT NOTICED A FLASHING RED LIGHT THAT WAS REPORTED ON (B)(6) 2016. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS REPORTED THAT THE SUBJECT HAS AN OPEN CIRCUIT OF THE IMPLANTED ANTERIOR LEAD. THERAPY IS NOT BEING DELIVERED.
N
Patient 1
DEVICE NOT YET RETURNED.
D
Patient 1
THIS SUBJECT IS A PARTICIPANT IN THE RECHARGE CLINICAL TRIAL. THIS SUBJECT WAS ORIGINALLY IN THE CONTROL ARM OF THE TRIAL AND UNDERWENT IMPLANTATION OF THE ACTIVE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2014. SUBJECT NOTICED A FLASHING RED LIGHT THAT WAS REPORTED ON (B)(6) 2016. DURING A CLINIC VISIT ON (B)(6) 2016, IT WAS REPORTED THAT THE SUBJECT HAS AN OPEN CIRCUIT OF THE IMPLANTED ANTERIOR LEAD. THERAPY IS NOT BEING DELIVERED. SUPPLEMENT 001: SUBJECT UNDERWENT REVISION OF THE MAESTRO RECHARGEABLE SYSTEM ON (B)(6) 2017. BECAUSE THE ANTERIOR LEAD WAS TWISTED WITH THE POSTERIOR LEAD, ALL DEVICE COMPONENTS WERE REPLACED. REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADVERSE IMPACT TO SUBJECT. EXPLANTED DEVICE COMPONENTS HAVE NOT YET BEEN RECEIVED BY ENTEROMEDICS. REFERENCE MDR 3005025697-2017-00014 FOR REPORT RELATED TO THE POSTERIOR LEAD.